FDA.reportPublic FDA data

Ancalima Zinc Oxide

Manufacturer
ANCALIMA LIFESCIENCES LIMITED
Effective date
2021-01-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:36:49

Label at a glance#

ProductAncalima Zinc Oxide
Active ingredientZINC OXIDE
Label structure11 sections

Indications and uses

■ helps treat and prevent diaper rash ■ dries the oozing and weeping of ■ poison ivy ■ poison oak ■ poison sumac

Dosage and administration

■ for diaper rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak sumac ■ apply ointment liberally as often as needed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20% w/w

Purpose

OTC - PURPOSE SECTION

Diaper Rash Cream

Uses

INDICATIONS & USAGE SECTION

■ helps treat and prevent diaper rash ■ dries the oozing and weeping of ■ poison ivy ■ poison oak ■ poison sumac

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

■ do not get into eyes

■ do not use over large areas of the body

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ the condition worsens ■ symptoms last more than 7 days or clear up and occur again in a few days ■ if you are allergic to any of these ingredients

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

■ for diaper rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak sumac ■ apply ointment liberally as often as needed

Other Information

SPL UNCLASSIFIED SECTION

■ store at 59-86F (15-30C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

cetostearyl alcohol, cetomacrogol 1000, light liquid paraffin, white soft parrafin

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display & Drug Fact PanelPrincipal Display & Drug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198911zinc oxide 20 % Topical OintmentPSN4
198911zinc oxide 0.2 MG/MG Topical OintmentSCD4
198911zinc oxide 20 % Topical OintmentSY4
198911zinc oxide 200 MG per GM Topical OintmentSY4
198911ZNO 0.2 MG/MG Topical OintmentSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73014-3040-32023-01-30C16284748780-1f386c649-a45f-0266-e053-dadaa90a7c1aAncalima Zinc oxide 20%
73014-3040-42023-01-30C16284748780-1f386c649-a45f-0266-e053-dadaa90a7c1aAncalima Zinc oxide 20%
73014-3040-52023-01-30C16284748780-1f386c649-a45f-0266-e053-dadaa90a7c1aAncalima Zinc oxide 20%
73014-3040-62023-01-30C16284748780-1f386c649-a45f-0266-e053-dadaa90a7c1aAncalima Zinc oxide 20%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73014-3040-3Ancalima Zinc Oxide28 g in 1 TUBEOINTMENT284
73014-3040-4Ancalima Zinc Oxide56 g in 1 TUBEOINTMENT564
73014-3040-5Ancalima Zinc Oxide425 g in 1 JAROINTMENT4254
73014-3040-6Ancalima Zinc Oxide453 g in 1 JAROINTMENT4534

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73014-3040ANCALIMA ZINC OXIDE (ZINC OXIDE) OINTMENT [ANCALIMA LIFESCIENCES LIMITED]4Legacy NDC, 4 package rows20210113_860e92cc-13fb-1810-e053-2991aa0a9a6e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73014-304073014-3040-3, 73014-3040-4, 73014-3040-5, 73014-3040-6

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-20I835H2IHHXIACT
LIGHT MINERAL OILN6K5787QVPIACT
PETROLATUM4T6H12BN9UIACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b8b4cab4-8d35-7b90-e053-2a95a90a9987860e92cc-13fb-1810-e053-2991aa0a9a6e2021-01-12WarningsExact identifier
spl id: b8b4cab4-8d35-7b90-e053-2a95a90a9987
spl set id: 860e92cc-13fb-1810-e053-2991aa0a9a6e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.